Center for Professional Innovation & Education, Inc., Malvern, PA
July 27 & 28, 2016
The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make it a straightforward process to get products approved in each country - but is it? This course works through the requirements for medical devices, the steps to obtain entry into the marketplace (including setting up a number of on-going procedures and relationships), and shares some lessons learned from the Course Director, who has over 20 years of experience with CE marking medical devices for distribution in the EU. The course will introduce the Medical Device Directives (AIMD, MDD & IVDMDD), the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the significance of Notified Bodies, Competent Authorities, and Authorized Representatives. Additionally, the significance of the QMS, ISO 13485 and ISO 14971, and reference to ISO 14000 will be explained as necessary elements in addressing the essential requirements, technical dossiers, declarations of conformity and the six steps required for manufacturers to market medical devices in the European market. Throughout the course, examples and case studies will help participants apply the concepts being covered.
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Invited Speakers:
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Jonathan Lee has more than 25 years of broad-based medical device experience with extensive Quality System experience encompassing ISO, MDD & GMP standards and regulations, through consulting and senior management positions in QA/RA, R&D, Project Management, Product Management, and Product Introduction disciplines, in both the United States and Australia A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic. In addition, his consulting roles supporting implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation system, surgical tool, vertebral stiffness measuring system, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, and product approvals, have provided for an extensive accumulated experience. Today, as Principal Consultant and Managing Member of “MedDev Consulting Solutions International” he provides strategic direction and tactical solutions for unique medical device challenges. Including areas such as integration of quality systems with compliance, product performance and elevated stakeholder expectations. Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University. He has participated in compliance symposia at Harvard University and served as an instructor on quality systems at University of Southern California School of Pharmacy Master’s Degree Program.
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